Aventus Thrombectomy System Pulmonary Embolism Clinical Study

Last updated: March 13, 2025
Sponsor: Inquis Medical, Inc.
Overall Status: Completed

Phase

N/A

Condition

Thrombosis

Venous Thromboembolism

Lung Disease

Treatment

Thrombectomy

Clinical Study ID

NCT05907564
CT-0001
  • Ages 18-80
  • All Genders

Study Summary

Evaluate the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in subjects with acute pulmonary embolism.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 80 years

  2. Subject or legally authorized representative (LAR) is willing and able to providewritten informed consent prior to receiving any non-standard of care protocolspecific procedures

  3. Subject is willing and able to comply with all protocol required follow-up visits

  4. PE symptom(s) duration ≤ 14 days from index procedure

  5. PE diagnosis ≤ 48 hours prior to index procedure

  6. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonaryartery based on Investigator determination)

  7. CTA evidence of dilated RV with an RV/LV ratio of ≥ 0.9 at baseline based onInvestigator determination

  8. Systolic blood pressure ≥ 90 mmHg without need for vasopressors (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with intravenous fluids prior toindex procedure)

  9. Stable heart rate < 130 BPM prior to index procedure

  10. Subject is deemed medically eligible for interventional procedure(s), perinstitutional guidelines and clinical judgment

Exclusion

Exclusion Criteria:

  1. Prior PE ≤ 180 days from index procedure

  2. Current hospitalization for other condition(s)

  3. Thrombolytic use ≤ 14 days of baseline CTA

  4. Pulmonary hypertension with peak pulmonary artery systolic pressure > 70 mmHg byright heart catheterization

  5. FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%

  6. Hematocrit < 28% within 6 hours of index procedure

  7. Platelets < 100,000/μL

  8. Serum creatinine > 1.8 mg/dL

  9. International normalized ratio (INR) > 3

  10. Presence of intracardiac lead in the right ventricle or right atrium placed < 180days prior to index procedure

  11. Cardiovascular or pulmonary surgery ≤ 7 days prior to index procedure

  12. Actively progressing cancer treated by chemotherapeutics

  13. Known bleeding diathesis or coagulation disorder

  14. Left bundle branch block

  15. History of severe or chronic pulmonary arterial hypertension

  16. History of chronic left heart disease with left ventricular ejection fraction ≤ 30%

  17. History of uncompensated heart failure

  18. History of underlying lung disease that is oxygen dependent

  19. History of chest irradiation

  20. History of heparin-induced thrombocytopenia (HIT)

  21. Any contraindication to systemic or therapeutic doses of heparin or anticoagulants

  22. Known anaphylactic reaction to radiographic contrast agents that cannot bepretreated

  23. Imaging evidence or other evidence that suggests, in the opinion of theInvestigator, the Subject is not appropriate for aspiration thrombectomyintervention such as the inability to navigate to target location, predominantlychronic clot or non-clot embolus

  24. Life expectancy of < 90 days, as determined by Investigator

  25. Female who is pregnant or nursing

  26. Current participation in another investigational drug or device treatment study thathas not reached the primary endpoint or the Investigator feels would impact theirability to participate in this clinical trial

  27. Subject has known residual Iliac Deep Vein Thrombosis (DVT), Inferior Vena Cava (IVC) clot or clot in transit (right atrium and/or right ventricular)

  28. Subject on extracorporeal membrane oxygenation (ECMO)

Study Design

Total Participants: 130
Treatment Group(s): 1
Primary Treatment: Thrombectomy
Phase:
Study Start date:
September 20, 2023
Estimated Completion Date:
February 20, 2025

Connect with a study center

  • Honor Health

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • NorthBay Medical Center

    Fairfield, California 94533
    United States

    Site Not Available

  • MemorialCare

    Long Beach, California 90806
    United States

    Site Not Available

  • El Camino Health

    Mountain View, California 94040
    United States

    Site Not Available

  • Sutter Health

    Sacramento, California 95816
    United States

    Site Not Available

  • Hartford Hospital

    Hartford, Connecticut 06102
    United States

    Site Not Available

  • Medstar

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois 60007
    United States

    Site Not Available

  • Ascension Illinois

    Elk Grove Village, Illinois 60007
    United States

    Active - Recruiting

  • Ascension St. Vincent

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Ochsner Health

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • McLaren Health Care

    Bay City, Michigan 48708
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Ascension Providence

    Southfield, Michigan 48075
    United States

    Site Not Available

  • CentraCare Heart and Vascular

    Saint Cloud, Minnesota 56303
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Holy Name Medical Center

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Ichan School of Medicine at Mount Sinai

    New York, New York 10019
    United States

    Site Not Available

  • University Hospitals

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • OhioHealth Research Institute

    Columbus, Ohio 43214
    United States

    Site Not Available

  • ProMedica - Jobst Vascular

    Toledo, Ohio 43606
    United States

    Site Not Available

  • Ascension St. John

    Tulsa, Oklahoma 74006
    United States

    Site Not Available

  • The Miriam Hospital

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Centennial Medical Center (HCA)

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Ascension Seton

    Austin, Texas 78705
    United States

    Site Not Available

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